None listed
Conditions
Brief summary
The Australian Epilepsy Project (AEP) is a large scale project with a planned 4000 participants using a package of both established and experimental testing in epilepsy to improve our ability to both provide accurate prognosis and diagnose surgically-curable disease. The package will include advanced MRI, neuropsychological assessment and genetic testing.
Interventions
Advanced MRI, Neuropsychological Assessment and genetic testing.
The study requires a single MRI acquisition which will be performed as a 90-minute session, with an optional out-of-scanner break of up to 15 minutes during the session. In overview, the acquisition will include structural imaging (comparable to a clinical epilepsy baseline MRI) as well as functional, diffusion and quantitative imaging sequences. The imaging plan will be the same for all participants. No injected contrast agent
Advanced MRI, Neuropsychological Assessment and genetic testing. The study requires a single MRI acquisition which will be performed as a 90-minute session, with an optional out-of-scanner break of up to 15 minutes during the session. In overview, the acquisition will include structural imaging (comparable to a clinical epilepsy baseline MRI) as well as functional, diffusion and quantitative imaging sequences. The imaging plan will be the same for all participants. No injected contrast agents will be used in the study. Participants will be asked to complete various tasks while inside the MRI Scanner such as responding to images by pushing buttons and watching select video images. The MRI's will be conducted at selected Hubs around Australia by experienced radiographers trained in the conduct of the study. A package of Neuropsychological Assessment will be delivered via telehealth by trained neuropsychologists at the start of the study. the battery of tests used will include 10 tests to be administered in less than two hours. The battery is aimed at cognitive domains particularly important in Epilepsy. Examples of the tests are Trail making, verbal fluency and digit span tests. The Genetic testing will be a chromosomal microarray looking at changes that can contribute to epilepsy and a biobanking sample. This will occur at the baseline of the study and require a nasal swab and blood test. the testing will be performed by trained study personnel at each hub. The testing will be timed to coincide with the availability of MRI Scanning and will be flexibly scheduled depending on participant availability and convenience. These tests are not repeated after baseline. Study staff will keep records of participation and ensure all activities are conducted and checked on the project database
Sponsors
Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria - Able to consent for themselves - Over 18 and less than 65 years of age - Able to understand the process of the study - Fluent in English - Referred by a Neurologist AND an EEG has been ordered or completed - First-ever seizure cohort - Diagnosis made no more than 3 months before referral - Participants must have only ever had one unprovoked seizure, or cluster of seizures on a single day, that occurred no more than 6 months before referral - Participants can be included with: - Past history of febrile seizures - Past history of provoked seizure(s) as per the ILAE (International League Against Epilepsy) definition 86 New diagnosis of epilepsy cohort - At least two unprovoked seizures (over any time frame, the most recent within 6 months of referral) - Diagnosis of epilepsy made within 6 months of referral OR One seizure within 6 months of referral AND one or more of; - Epileptiform discharges on EEG - Epileptogenic lesion on CT - Epileptogenic lesion on MRI - Untreated or treated with anti-seizure medications (ASM) for less than 6 months at the time of referral Drug-resistant epilepsy cohort - Focal (or combined focal and generalised) epilepsy, with or without likely causative lesion on MRI - At least one seizure in the 6 months prior to referral - Two appropriate drugs in adequate doses have failed due to lack of efficacy (‘appropriate’ and ‘adequate’ as decided by the treating neurologist), including previous and current ASMs (e.g. on 1 current ASM and previously failed 1 or more ASM, or on 2 or more current ASMs)87 - Currently taking at least one ASM Healthy Volunteers inclusion criteria: Inclusion criteria - Able to consent for themselves - Over 18 and less than 65 years of age - Able to understand the process of the study - Fluent in English
Exclusion criteria
Exclusion criteria - Contraindications to research MRI scanning (including certain metal foreign bodies, pregnancy, severe claustrophobia, etc…) - Developmental and Epileptic Encephalopathies (DEE) - Moderate or severe intellectual disability - Seizures solely due to provoking medical condition, medication, drug or alcohol use - Age over 65 or under 18 at recruitment. - Severe, intercurrent or progressive illness likely to EITHER - Have a prognosis for survival under 24 months OR - In the opinion of the investigator will mask the importance to the individual participant of any improvement in their seizures (e.g. severe MS, dementia, etc) OR - Which leads to moderate disability requiring help with daily activities (equivalent to modified Rankin Score of 3 or more) Note that disability solely due to frequency and severity of seizures is NOT an exclusion criterion. First-ever seizure cohort - More than one unprovoked seizure ever - Febrile seizures with the last seizure before 6 years of age are permitted Newly diagnosed epilepsy cohort - Treated with ASM for epilepsy for more than 6 months at the time of referral. - Treatment with ASM for other indications (e.g. neuropathic pain) is NOT an exclusion criteria Those treated for more than 6 months are no longer “Newly Diagnosed”, although they may qualify as Drug-Resistant in some cases Drug-resistant epilepsy cohort - Genetic generalised epilepsy syndromes - Focal and generalised epilepsy syndromes where the focal seizures are associated with photosensitivity, such as idiopathic photosensitive occipital epilepsy, will not be included. Other generalised epilepsy syndromes Healthy Volunteer - Exclusion criteria - Ever had provoked or unprovoked seizure(s) - Febrile seizures with the last seizure before 6 years of age are permitted - Contraindications to research MRI scanning (including certain metal foreign bodies, pregnancy, severe claustrophobia, etc…) - Moderate or severe intellectual disability - Age over 65 or under 18 at recruitment. - Severe, intercurrent or progressive illness likely to EITHER - Have a prognosis for survival under 24 months OR In the opinion of the investigator would have masked the importance to the individual participant of any improvement if included as an epilepsy participant (e.g. severe MS, dementia, etc) OR Which leads to moderate disability requiring help with daily activities (equivalent to modified Rankin Score of 3 or more) - Have a condition that would preclude participation in project activities
Outcome results
None listed